New FDA Medical Device Tracking System

On September 20, 2013, the Food and Drug Administration (FDA) announced a final rule for the unique device identification system (UDI) that will provide a consistent way to identify medical devices.

How the New Rule Will Affect the Consumer

By improving the quality of information in medical device adverse events reports, the UDI system will help the FDA identify product problems more quickly, produce better target recalls, and improve patient safety.

Once fully implemented, the UDI system rule is expected to have many benefits for patients, the health care system and the device industry.

The new system will:

Enhance the ability to quickly and efficiently identify marketed devices when recalled

Improve the accuracy and specificity of adverse event reports

Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion

Offer a clear way of documenting device use in electronic health records and clinical information systems

The UDI system will enable more reliable data on how medical devices are used, which will promote safe device use by providers and patients and enable faster, more innovative and less costly device development.

Copyright @ 2016 Richard H. Rizk, Attorney at Law | All Rights Reserved | Richard H. Rizk is licensed to practice law in Oregon, Washington, Illinois, and Federal District Court, and is a member of the Oregon Trial Lawyers.